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About Sialanar®

Sialanar® is an oral solution for children and adolescents aged 3 years and older with chronic neurological disorders for the management of chronic pathological drooling (severe sialorrhoea).1

It has raspberry flavouring, a titration schedule based upon patient’s weight and is suitable for administration orally or via feeding tubes.1

Designed for Children

Tailored titration for flexible and accurate dosing1

60% less volume vs.1mg/5ml glycopyrronium oral solutions, helping to improve patient acceptability and tolerability1-6

Minimal excipients to reduce toxicity risk - sugar, alcohol and sorbitol free 1,6,7,8

Why is volume important?
  • The dose volume is a major consideration for the acceptability of a liquid formulation6
  • The maximum recommended single dosing volume for paediatric liquid formulations for typically developing children is <5ml for children under 5 years and <10ml for children of 5 years and older5
  • Eating, drinking and swallowing difficulties (dysphagia) are common in children with neurodisability9
  • Initial research suggests even Cerebral Palsy patients at EDACs level I may have a reduced dysphagia limit in comparison to typically developing children, with a median of 7ml10
Why are excipients important
  • Excipients are a necessary component of almost all medicines, but they may be present in quantities which are potentially harmful to babies and children6
  • Excipients used in adult formulations may not be appropriate for paediatric use so have the potential to lead to adverse effects8
  • Oral doses of sorbitol which are greater than 140mg/kg/day may result in increased gastrointestinal (GI) side effects, including osmotic diarrhoea, abdominal pain, bloating and GI discomfort7,8

 

Watch the excipients animation

Sialanar® is designed for children, using sucralose as a sweetener instead of sorbitol1 and is suitable for patients on a ketogenic diet (<5mg/ml carbohydrate)1,11

Why is treating drooling important?

Sialorrhoea can cause significant clinical problems and negatively impact quality of life for patients and carers12,13


Physical consequences

  • Posterior sialorrhoea: can lead to aspiration, increasing the risk of respiratory infections, hospitalisations and mortality14-16

  • Anterior sialorrhoea: can cause infections, macerated skin, interference with feeding and dehydration13

  • Aspiration can develop silently so may not be diagnosed prior to development of more serious lung issues14
  • Respiratory illness is the leading cause of hospitalisations and mortality in young people with cerebral palsy, 25% of patients (4-5 GMFCS) suffer from chronic respiratory problems16,17


Management of sialorrhoea is recommended to reduce risk factors for aspiration, helping to prevent further respiratory illness15

Psychosocial concerns

  • Social embarrassment, isolation and low self-esteem13
  • Increased dependency and level of care13
  • Barriers to education (damage and inability to share books / computers) 13

Resources

Visit the resources section to find product support materials for patients/carers and educational resources for healthcare professionals.

Resources

Dosing and Titration

Head to this section to find out more about the dosing and titration schedule for Sialanar®.

Dosing and Titration

Clinical Evidence

Glycopyrronium has demonstrated lower rates of problematic side effects18 and treatment cessation18,19 vs. hyoscine.

Clinical Evidence

References

  1. Sialanar® SmPC (January 2023) https://www.medicines.org.uk/emc/product/2301 – accessed August 2023
  2. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Colonis Pharma) SmPC (July  2024) https://www.medicines.org.uk/emc/product/7344/smpc
  3. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Rosemont Pharmaceuticals Limited) SmPC (January 2022) https://www.medicines.org.uk/emc/product/13136/smpc
  4. Glycopyrronium Bromide 1 mg/5 ml Oral Solution (Strandhaven Limited t/a Somex Pharma UK Limited) SmPC (October 2022) https://www.medicines.org.uk/emc/product/14104/smpc
  5. Batchelor H & Marriot J. BJCP 2015. Formulations for Children: Problems and Solutions https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.12268 ) - accessed August 2023
  6. NPPG Positioning statement 2020-21 available at http://nppg.org.uk/choosing-an-oral-liquid-for-a-child/ - accessed August 2023
  7. Rouaz K, et al. Excipients in the paediatric population: a review. Pharmaceutics 2021; 13(3): 387.
  8. Arthur S. How to identify and manage ‘problem’ excipients in medicines for children. The Pharmaceutical Journal 2017. Available at: https://pharmaceutical-journal.com/article/ld/how-to-identify-and-manage-problem-excipients-in-medicines-for-children – accessed August 2023
  9. Taylor H, Pennington L, Craig D, et al. Children with neurodisability and feeding difficulties: a UK survey of parent-delivered interventions. BMJ Paediatrics Open 2021;5:e001095. doi:10.1136/ bmjpo-2021-001095
  10. Schepers, F. V., van Hulst, K., Spek, B., Erasmus, C. E., & van den Engel-Hoek, L. (2022). Dysphagia limit in children with cerebral palsy aged 4 to 12 years. Developmental medicine and child neurology, 64(2), 253–258. https://doi.org/10.1111/dmcn.15031
  11. Data on file
  12. Collins A, et al. Management of drooling in children with cerebral palsy. Paediatrics & Child Heath 2020. 30(12): 425-429.
  13. Güvenç I.A. Sialorrhea: A guide to etiology, assessment, and management. In (Ed.), Salivary Glands - New Approaches in Diagnostics and Treatment. IntechOpen 2018. https://doi.org/10.5772/intechopen.82619.
  14. Erasmus C.E, et al. Swallowing problems in cerebral palsy. European Journal of Pediatrics 2012; 171: 409-414.
  15. American Academy for Cerebral Palsy and Developmental Medicine. Respiratory health in cerebral palsy. Available at: https://www.aacpdm.org/publications/care-pathways/respiratory-health-in-cerebral-palsy. accessed July 2023
  16. Gibson N, et al. Prevention and management of respiratory disease in young people with cerebral palsy: consensus statement. Developmental Medicine & Child Neurology 2021; 63: 172-182.
  17. Gregson E, et al. Pseudomonas aeruginosa infection in respiratory samples in children with neurodisability-to treat or not to treat? Eur J Pediatr. 2021; 180(9): 2897-2905.
  18. Parr J.R, Todhunter E, Pennington L, et al. Drooling Reduction Intervention randomized trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability. Arch Dis Child 2017; 1-6. Doi:10. 1136/ archdischild-2017-313763.
  19. Reid S.M, et al. Anticholinergic medications for reducing drooling in children with developmental disability. Developmental Medicine & Child Neurology 2019; 63(3): 346-353

 

UK-SIA-25-0062 | October 2025

Adverse Event Reporting Information

UK: Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard. 

Republic of Ireland: Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie.

Adverse events should also be reported to Proveca Limited. Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

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